MEDRAD® Mark 7 Arterion Injection System (REF ART 700 PEDL, ART 700 TABL, ART 700 OCS, ART 700 BASC, ART 700 VFL)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00616258021362), received between Oct 11, 2023 and Dec 11, 2023 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K112086); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON NOVEMBER 15, 2023, BAYER MEDICAL CARE INC. RECEIVED INFORMATION THAT A PATIENT SUFFERED A CARDIAC ARREST WHILE CONNECTED TO A MEDRAD® MARK 7 ARTERION INJECTION SYSTEM (SERIAL NUMBER (B)(6). THE CUSTOMER REPORTED THAT THE INJECTOR FAILED TO RESPOND AFTER BEING ARMED. AS THE STAFF WERE ATTEMPTING TO TROUBLESHOOT THE INJECTOR ISSUE, THE PATIENT'S BLOOD PRESSURE DROPPED WHICH PROGRESSED TO CARDIAC ARREST. THE CUSTOMER REPORTED THAT, AFTER SUCCESSFUL RESUSCITATION, THE INJECTOR WAS RETURNED TO NORMAL OPERATION AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE CUSTOMER ALSO REPORTED THAT THE PATIENT HAS RECOVERED.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 18303171 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A PATIENT DEATH AND POTENTIAL BUT UNCONFIRMED AIR INJECTION OCCURRED WHILE A MEDRAD® MARK 7 ARTERION INJECTION SYSTEM (SERIAL NUMBER (B)(6)) WAS IN USE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17916338 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112086. One submission often covers many models, so check the product and lot details in each record.

• Z-0745-2019 · Dec 14, 2018 · Terminated
  MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Inje